Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.

Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Toxicity, as a measure of safety and tolerability, is assessed by the percent of participants with adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC). Possible toxicities include neutropenia, anemia, thrombocytopenia, nausea and vomitting, allergy, and so on.

Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.

Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc.

Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

female patients with metastatic breast cancer

Criteria

Inclusion Criteria:

Histologically confirmed metastatic breast cancer

Female

An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

At least one measurable lesion

Normal cardiac, hepatic, renal and bone marrow functions

Life expectancy ≥3 months

Discontinuity of previous chemotherapy for a minimum of 4 weeks

Exclusion Criteria:

Central nervous system metastases

Serious or uncontrolled concurrent medical illness

History of other malignancies

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199393